Early prediction of adalimumab levels with InsightRx

Completed

Conditions: Inflammatory Bowel Diseases (M.Crohn and Ulcerative Colitis) and Rheumatic diseases (Rheumatoid Arthritis
Psoriatic Arthritis
Spondyloarthropathy)
10017969
10023213

Registration Number: NL-OMON49110

Lead Sponsor: Maxima Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

All adult patients over 18 years of age with new adalimumab prescriptions at
initial dosing interval of 14 days for rheumatic diseases (RA,PsA,SpA) or
inflammatory bowel disease (UC, Crohn*s disease) will be eligible to
participate in our study.

Exclusion Criteria

* Pregnancy
* Previous adalimumab use
* Allergy for adalimumab or excipients (Humira)
* Patients unable or unwilling to consent to participation to this trial

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Accuracy of adalimumab level at steady-state prediction, based on early TDM. To<br /><br>numerically quantify the bias and precision, model-predicted levels shall be<br /><br>compared to the observed values in the datasets. MPE (bias) and normalised RMSE<br /><br>(precision) of the individual weighted residuals will be calculated using<br /><br>Microsoft Excel:<br /><br>Normalised RMSE is RMSE divided by (maximal dependant variable minus minimal<br /><br>dependant variable).<br /><br>Precise model prediction is defined as MPE and normalised RMSE < 25% (5,6,7). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>With the newly collected adalimumab levels and anti-adalimumab antibodie titers<br /><br>(and more detailed timing of administration data) new PK parameters will be<br /><br>estimated with NONMEM for both IBD and rheumatic disease population. </p><br>